Allegra telfast 180

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Allegra Telfast 180 (Fexofenadina Opella 180 mg)
180 mg, film-coated tablets
Fexofenadini hydrochloridum
Allegra Telfast 180 and Fexofenadina Opella 180 mg are different trade names of the same
medicinal product.
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What is Allegra Telfast 180 and what it is used for
2. Important information before taking Allegra Telfast 180
3. How to take Allegra Telfast 180
4. Possible side effects
5. How to store Allegra Telfast 180
6. Contents of the pack and other information

1. What is Allegra Telfast 180 and what it is used for

Allegra Telfast 180 contains fexofenadine hydrochloride, which is an antihistamine medicine.
Allegra Telfast 180 is used in adults and children aged 12 years and above for the treatment of
symptoms of chronic allergic skin reactions (chronic idiopathic urticaria), such as itching, swelling, and rash.

2. Important information before using Allegra Telfast 180

When not to use Allegra Telfast 180:

• if the patient is allergic to hydrochloride of fexofenadine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Allegra Telfast 180, discuss it with your doctor.
When to exercise special caution when using Allegra Telfast 180:

• if the patient has impaired kidney or liver function,
• if the patient currently has or has previously had a cardiovascular disorder, as this medicine may cause rapid or irregular heartbeat,
• if the patient is elderly. If any of the above conditions apply to the patient or if the patient has any doubts, they should consult a doctor before using this medicine.

Allegra Telfast 180 and other medicines
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Inform your doctor about all medicines currently or recently taken,
as well as any medicines the patient intends to use.
If the patient is taking apalutamide (a medicine used to treat prostate cancer), the effect of fexofenadine
may be reduced.
Taking antacids containing aluminium and magnesium may affect the action of Allegra Telfast 180 by reducing the amount of medicine absorbed. Therefore, it is recommended to maintain a two-hour interval between taking the aforementioned antacids and administration of Allegra Telfast 180.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Allegra Telfast 180 should not be used during pregnancy unless absolutely necessary.
Use of Allegra Telfast 180 during breastfeeding is not recommended.
Driving and operating machinery
It is unlikely that Allegra Telfast 180 will affect the ability to drive or operate machinery. However, before driving or operating mechanical equipment, ensure that the medicine does not cause drowsiness or dizziness.
Allegra Telfast 180 contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Allegra Telfast 180

This medicine should always be taken as directed by a physician. If in doubt, consult a doctor or pharmacist.
For adults and children over 12 years of age
The recommended dose is 1 tablet (180 mg) once daily.
Tablets should be taken orally, before a meal, with water.
Taking more Allegra Telfast 180 than recommended
If more than the recommended dose is taken, seek medical advice immediately or go to the nearest hospital. Symptoms of overdose may include dizziness, drowsiness, fatigue, and dry mouth.
If you miss a dose of Allegra Telfast 180
Do not take a double dose to make up for the missed dose.
Take the next dose according to the dosing schedule prescribed by your doctor.
Stopping Allegra Telfast 180
If the patient wishes to discontinue treatment with Allegra Telfast 180, they should consult their doctor beforehand. If treatment with Allegra Telfast 180 is stopped earlier than recommended, symptoms of the disease may return.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine may cause adverse effects, although not everyone will experience them.
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You should seek immediate medical advice and stop taking Allegra Telfast 180 if you develop swelling of the face, lips, tongue or throat, and have difficulty breathing. These may be symptoms of a severe allergic reaction.
Common adverse effects (occurring in less than 1 in 10 but more than 1 in 100 patients): headache, drowsiness, nausea, and dizziness.
Uncommon adverse effects (occurring in less than 1 in 100 but more than 1 in 1000 patients): fatigue.
Other adverse effects (frequency unknown) which may occur include: difficulty falling asleep (insomnia), sleep disturbances, nightmares/vivid dreams, nervousness, blurred vision, rapid or irregular heartbeat, diarrhoea, skin rash and itching, urticaria, severe allergic reactions which may cause swelling of the face, lips, tongue and throat, difficulty breathing (dyspnoea), feeling of tightness in the chest, sudden redness of the skin.
If any of the adverse effects worsen, or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported to the marketing authorisation holder or its representative in Poland.
By reporting adverse effects, additional information on the safety of this medicine can be collected.

5. How to store Allegra Telfast 180

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Allegra Telfast 180 contains

• The active substance in Allegra Telfast 180 is fexofenadine hydrochloride. Each tablet contains 180 mg of fexofenadine hydrochloride.
• The other ingredients are:

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Core tablet composition: sodium croscarmellose, pregelatinized corn starch, microcrystalline cellulose, magnesium stearate.
Coating composition: Hypromellose E-15, hypromellose E-5, povidone, titanium dioxide (E 171),
anhydrous colloidal silica, macrogol 400, iron oxide (E 172).
What Allegra Telfast 180 looks like and contents of the pack
Allegra Telfast 180 tablets are peach-coloured, capsule-shaped and marked
“018” on one side and “e” on the other.
Allegra Telfast 180 tablets are packed in blisters and boxed in a cardboard outer.
The pack contains 20, 50 or 100 coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Spain, the country of export:
Opella Healthcare Spain, S.L., C/ Rosselló i Porcel, 21, 08016 – Barcelona, Grupo Sanofi, Spain
Manufacturer:
Opella Helathcare International SAS, 56, route de Choisy, 60200 Compiègne, France
Sanofi-Winthrop Industrie, Avenue Gustave Eiffel, 30 – 36, 37100 Tours, France
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation Number in Spain, the country of export: 663351.9
Parallel Import Authorisation Number: 102/24
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